510(k) Report

Devices descending from K111689

22 later devices reach Stlase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163128Epic ProBiolase, Inc.201716—
+1K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+2K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+2K193656SkyPulseFotona D.O.O.202011—
+2K172771Epic Pro 940Biolase, Inc.20171—
+2K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K200693K2 MobileHulaser, Inc.20202—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—